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Johnson & Johnson · 9 hours ago

Sr Eng Process Engineering

Irving, Texas, United States of America

Full-time

Onsite

Senior Level

Johnson & Johnson is a leader in healthcare innovation, focusing on developing smarter and less invasive treatments. The Sr Eng Process Engineering role involves planning and executing new process development to launch high-quality products while ensuring compliance with safety and regulatory standards.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Plans, documents, and executes new process development, designed experiments, validations, qualifications, testing, and design control deliverables in order to launch high-quality, compliant new products into manufacturing while meeting time, cost and margin targets

Monitors and supports new product processes until stabilized, and fully transferred into production

Manages and executes projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met

Provides project management guidance and business tools, utilizing a systematic approach to project execution

Prepares management reports and presentations

Effective project planning and structure

Develops imaginative strategies for the efficient completion of projects

Sets the engineering standard and direction for the group and is recognized as the source for guidance in a field

Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner

Challenges the “status quo” on a routine basis and develops new ideas within incoming processes

Coordinates phases of work with other departments within the company and with other Ethicon divisions

Technical support to Manufacturing Business Units for complex process issues, where higher level of technical expertise in a given field of knowledge is required

Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations

Revise and maintain engineering, equipment and process procedures

Participates in GMP audits regarding equipment recording and machine performance

Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers

Participates in projects involving other departments and activities (CIM, QIP, CFM, etc.)

Writes, develops and implements validation procedures

Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department

Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results

Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs)

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualification

Process EngineeringValidation TestingLean Supply Chain ManagementTechnical ResearchCorrectivePreventive Action (CAPA)Agile Decision MakingCoachingEmerging TechnologiesIssue EscalationProcess ControlProduct CostingProduct ImprovementsSituational AwarenessTechnologically SavvyVendor SelectionCritical ThinkingProblem Solving

Required